510(k) K071075
K071075 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A". The FDA issued a decision of Substantially Equivalent on May 25, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Terumo Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2007
- Date Received
- April 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type